Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Cholecystectomies

NCT04587973 | Completed

• 1 other identifier: ESPB-Frida
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the trial is to study the efficacy of bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic cholecystectomy

Conditions

Pain, Postoperative; Pain Syndrome; Pain, Acute; Anesthesia; Cholecystectomy; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (6)

• pain score 3 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  3 hours after surgery

• pain score 6 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  6 hours after surgery

• pain score 12 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  12 hours after surgery

• pain score 24 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  24 hours after surgery

• pain score on arrival to Post-Anesthesia Care Unit (PACU)

  pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  immediately postoperatively

• pain score at discharge from Post-Anesthesia Care Unit (PACU), ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU

  immediately postoperatively

Secondary Outcomes (7)

• morphine consumption

  24 hours postoperatively

• satisfaction from postoperative analgesia

  24 hours postoperatively

• mobilization time

  24 hours postoperatively

• hospitalization time

  72 hours postoperatively

• intraoperative dose of remifentanil infusion (μg kg-1)

  intraoperatively

Study Arms (3)

Group Dexmedetomidine

ACTIVE COMPARATOR

Ropivacaine plus dexmedetomidine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml) plus dexmedetomidine 1 mcg/kg

Procedure: Group Dexmedetomidine

Group Ropivacaine

ACTIVE COMPARATOR

Plain ropivacaine group - Preoperative bilateral erector spinae plane block with ropivacaine 0,375% (40 ml)

Procedure: Group Ropivacaine

Group Control

PLACEBO COMPARATOR

Control group - Preoperative bilateral erector spinae plane block with N/S 0,9% (40 ml)

Procedure: Group Control

Interventions

Group Dexmedetomidine PROCEDURE

Ropivacaine plus dexmedetomidine group

Group Dexmedetomidine

Group Ropivacaine PROCEDURE

Plain ropivacaine group

Group Ropivacaine

Group Control PROCEDURE

Control group

Group Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, II
• Laparoscopic cholecystectomy
• Elective surgery

You may not qualify if:

• Patient refusal
• Coagulation disorders
• Known allergies to local anesthetics
• Other contraindications to regional anesthesia
• Infection or anatomic anomalies on injection site
• Uncontrolled hypertension
• Severe liver or kidney disease
• Pregnancy
• Known depression or psychiatric disorders, dementia
• Drug or alcohol abuse
• Inadequate command of Greek language

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

George Papanikolaou, General Hospital of Thessaloniki

Thessaloniki, 57010, Greece

Location

Related Publications (7)

• Ibrahim M. Erector Spinae Plane Block in Laparoscopic Cholecystectomy, Is There a Difference? A Randomized Controlled Trial. Anesth Essays Res. 2020 Jan-Mar;14(1):119-126. doi: 10.4103/aer.AER_144_19. Epub 2020 Feb 3.

  PMID: 32843804 BACKGROUND

• Herman JA, Urits I, Kaye AD, Urman RD, Viswanath O. Erector Spinae Plane Block (ESPB) or Quadratus Lumborum Block (QLB-II) for laparoscopic cholecystectomy: Impact on postoperative analgesia. J Clin Anesth. 2020 Nov;66:109958. doi: 10.1016/j.jclinane.2020.109958. Epub 2020 Jun 17. No abstract available.

  PMID: 32563073 BACKGROUND

• Kwon HM, Kim DH, Jeong SM, Choi KT, Park S, Kwon HJ, Lee JH. Does Erector Spinae Plane Block Have a Visceral Analgesic Effect?: A Randomized Controlled Trial. Sci Rep. 2020 May 21;10(1):8389. doi: 10.1038/s41598-020-65172-0.

  PMID: 32439926 BACKGROUND

• Peker K, Akcaboy ZN, Aydin G, Gencay I, Sahin AT, Kocak YF, Peker SA. The Effect of Erector Spinae Plane Block on Laparoscopic Cholecystectomy Anesthesia: Analysis of Opioid Consumption, Sevoflurane Consumption, and Cost. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):725-729. doi: 10.1089/lap.2019.0809. Epub 2020 Feb 5.

  PMID: 32023174 BACKGROUND

• Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.

  PMID: 31862217 BACKGROUND

• Raft J, Chin KJ, Gobert Q, Richebe P, Brulotte V. Defining the optimal analgesic strategy for erector spinae plane (ESP) blocks in unanticipated open cholecystectomy. Korean J Anesthesiol. 2019 Oct;72(5):504-505. doi: 10.4097/kja.d.18.00350. Epub 2018 Dec 28. No abstract available.

  PMID: 30590914 BACKGROUND

• Sifaki F, Mantzoros I, Koraki E, Bagntasarian S, Christidis P, Theodoraki K. The Effect of Ultrasound-guided Bilateral Erector Spinae Plane Block With and Without Dexmedetomidine on Intraoperative and Postoperative Pain in Laparoscopic Cholecystectomies: A Randomized, Controlled, Double-blind, Prospective Trial. Pain Physician. 2022 Oct;25(7):E999-E1008.

  PMID: 36288585 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Somatoform Disorders; Acute Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: June 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)